110th Congress

Appropriations for the National Institutes of Health, Fiscal Year 2007

H.R. 5647, H. Rept. 109-515, S. 3708, S. Rept. 109-287, H.J. Res. 20; P.L. 109-289; P.L. 109-369; P.L. 109-383; P.L. 110-5

Background

On January 29, 2007, Representative David R. Obey (D-WI) introduced H.J. Res. 20, the Revised Continuing Appropriations Resolution, 2007, hereafter called the Joint Resolution. This measure, which provides funding through September 30, 2007, was passed by the House on January 31, 2007, and by the Senate on February 14. On February 15, it was signed into law by the President as P.L. 110-5. The Joint Resolution provides funding for programs covered by the nine unfinished fiscal year (FY) 2007 appropriations bills. These are the Labor, Health and Human Services (HHS), Education, which includes the National Institutes of Health (NIH), as well as Agriculture; Energy and Water; Foreign Operations; Interior and the Environment; the Legislative Branch; Military Quality of Life and Veterans Affairs; Science, State, Justice, Commerce; Transportation, Treasury, Housing and Urban Development, the Judiciary, and the District of Columbia. This Joint Resolution provides funding to most programs at FY 2006 levels, with increases to fund pay increases. There is no report accompanying this resolution. General provisions that were included in the FY 2006 Appropriations Act remain in effect for FY 2007, or as stated in Section 101 of the Joint Resolution, “and under the authority and conditions provided in the applicable appropriations Act for fiscal year 2006, for projects or activities” with the exception of the “1 percent government-wide rescission made by section 3801 of division B of Public Law 109-148.”

Prior to this action, these agencies and departments were funded by a series of three continuing resolutions (CRs) (listed below). The November 2006 elections changed the landscape for FY 2007 appropriations action, resulting in the passage of a second CR immediately following the election, followed by a third CR after the Thanksgiving recess, which provided funding through February 15, 2007, and into the 110th Congress, when the Democrats took over the leadership in both the House and Senate.

CONTINUING RESOLUTIONS

Provisions Affecting NIH

The Joint Resolution includes a number of important program increases above the FY 2006 funding levels, including a $687 million increase for NIH. NIH estimates that the increase is sufficient to support 500 additional research project grants. Under a straight CR (funding at the current rate), that number would have risen by 470, partly because of NIH’s December 2006 guidance stating that there would be no inflationary adjustments for noncompeting renewal awards. Therefore, for FY 2007, there will be a total of 970 more research project grants than in FY 2006.

The Joint Resolution appropriates $483 million specifically for the Common Fund (formerly called the NIH Roadmap), a change from previous years’ appropriations. In previous years, each of the NIH Institutes and Centers (ICs) contributed a uniform percentage of its appropriation to the Fund. For FY 2007, most ICs will show a slight increase over the final FY 2006 level since they are no longer required to contribute to the Common Fund and therefore are effectively receiving an increase. (Congress did not specify the Fund amount in the NIH Reform Act (P.L. 109-482), which created the Common Fund statutorily.)

Common Fund: Of the $483 million for the Common Fund, $40 million is for the Director’s New Innovator Award, formerly the Junior Pioneer Award Program. Like regular Pioneer Awards, these awards will fund high-risk research with potentially high-impact returns. New Innovator Awards will provide smaller amounts of money for shorter amounts of time, but all funding will be received up front. The remaining $443 million base is a $113 million increase over the FY 2006 level.

Office of the Director (OD): There is a new $91 million fund within OD to support new investigators funded by the Director’s Bridge Awards.

National Children’s Study (NCS): The resolution also includes $69 million for the NCS, an increase of $58 million. An $11 million appropriation in the National Institute of Child Health and Human Development (NICHD) for the NCS in FY 2006 has been moved to OD, out of which the NCS will be funded, hence the $11 million reduction for NICHD.

Other ICs: There are increases for certain ICs that will benefit all diseases ($5 million for the National Library of Medicine, $4 million for the National Center on Minority Health and Health Disparities, and $34 million for the National Center for Research Resources for one-time projects) and about $7 million to implement initiatives in the NIH Reform Act.

The bill language in the Joint Resolution affecting NIH is as follows:

“Sec. 20614. (a) Notwithstanding section 101, the levels for the following accounts of the Department of Health and Human Services, National Institutes of Health, shall be as follows: ‘National Institute of Child Health and Human Development’, $1,253,769,000; ‘National Center for Research Resources’, $1,133,101,000; ‘National Center on Minority Health and Health Disparities’, $199,405,000; ‘National Library of Medicine’, $319,910,000; and ‘Office of the Director’, $1,095,566,000, of which up to $14,000,000 may be used to carry out section 217 of the Department of Health and Human Services Appropriations Act, 2006 (the flexible research authority), $69,000,000 shall be available to carry out the National Children’s Study, and $483,000,000 shall be available for the Common Fund established under section 402A(c)(1) of the Public Health Service Act (the latter created by the NIH Reform Act).

(b) The seventh, eighth, and ninth provisos under the heading ‘Department of Health and Human Services, National Institutes of Health, Office of the Director’ in the Department of Health and Human Services Appropriations Act, 2006, pertaining to the National Institutes of Health Roadmap for Medical Research, shall not apply to funds appropriated by this division. (These are: 7th—the uniform percentage of the amounts appropriated in this Act to each Institute and Center may be transferred; 8th—that the amount utilized shall not exceed $250,000,000 without prior notification to the Committees on appropriations; 9th—that amounts transferred and utilized under the two previous provisos shall be in addition to amounts made available for the Roadmap for Medical Research from the Director’s Discretionary Fund and to any amounts allocated to activities related to the Roadmap through the normal research priority-setting process of individual Institutes and Centers.)

(c) Funds appropriated by this division to the Institutes and Centers of the National Institutes of Health may be expended for improvements and repairs of facilities, as necessary for the proper and efficient conduct of the activities authorized herein, not to exceed $2,500,000 per project.” (This is a new provision.)

A chart displaying the actions of the Joint Resolution with the FY 2006 enacted levels is available at: officeofbudget.od.nih.gov/PDF/Final Conference by IC for Web.pdf.

Note: Subsequent to this action, Congress passed H.R. 2206, the Fiscal 2007 Second Emergency Iraq/Hurricane Supplemental Appropriations (signed into law as P.L. 110-28), which rescinded $99 million from the FY 2007 appropriation for NIH. (See the article entitled Supplemental Appropriations for Fiscal Year 2007 (Rescission for NIH)).

Summaries of the House and Senate hearings are provided in attachment 1. A history of House and Senate action is provided in attachment 2. A comparison chart of House and Senate provisions is provided as attachment 3.

ATTACHMENT 1
FY 2007 HEARINGS

HOUSE APPROPRIATIONS HEARING, APRIL 6, 2006

The April 6 hearing, chaired by Representative Ralph Regula (R-OH), was attended by 5 of the 10 Republican members and all the Democratic members. All Members but Representatives Regula and Anne M. Northup (R-KY) spoke in favor of an increase for NIH but acknowledged the limitations faced by the Chair, given the pending House Budget Resolution, which was on the floor at the time of the hearing.

Dr. Elias Zerhouni testified about the remarkable improvements in medical treatment over the past 30 years as a result of the investment of Congress in NIH. He emphasized that the doubling period, in particular, had accelerated research to the point that we are poised to use NIH-supported discoveries to transform the medical treatment paradigm in the 21st century from one that responds to symptoms to one that predicts disease, personalizes treatment, and preempts disease, striking disease before it strikes the patient.

Aside from the budget, major issues from the hearing were the absence in the budget of funding for the NCS; Representative Dave Weldon’s (R-FL) concerns about the possible link between the vaccine preservative thimerosal and increasing autism rates and his support for the current relevant National Institute of Environmental Health Sciences and National Institute of Allergy and Infectious Diseases (NIAID) studies; declining support for the Institutional Development Award (IDeA) program; support for public access and the need for a mandatory program; status of the Specialized Programs of Research Excellence in Ovarian Cancer; and a question from Representative Patrick J. Kennedy (D-RI), who asked whether NIH supports legislation to prevent genetic discrimination against patients whose medical records contain information about their genetic predispositions.

SENATE APPROPRIATIONS HEARING, MAY 19, 2006

Senator Arlen Specter (R-PA) presided over a 45-minute hearing on May 19 with NIH witnesses, followed by 1 hour of 90-second statements by 20 witnesses representing many of the major organizations supportive of NIH research. Senators Specter, Tom Harkin (D-IA), and Richard C. Shelby (R-AL) each decried the flat budget proposed for FY 2007, with Senator Specter stating that the NIH budget has already been cut by 10.4 percent in the last 2 years. Senator Shelby twice said, “I’m going to do everything I can as a member of the Appropriations Committee to help fund, properly fund, medical research through NIH.”

Dr. Zerhouni testified about the remarkable improvements in medical treatment over the past 30 years as a result of the investment of Congress in NIH. He emphasized that the doubling period, in particular, had accelerated research to the point that we are poised to use NIH-supported discoveries to transform the medical treatment paradigm in the 21st century from one that responds to symptoms to one that predicts disease, personalizes treatment, and preempts disease, striking disease before it strikes the patient. Dr. Zerhouni provided a passionate portrayal of the Agency’s past successes and a vision for the future of medicine. He testified that the per capita investment by Americans in NIH was relatively small in comparison with the achievements of medical research and the rising cost of health care.

Major issues from the hearing included the proposed budget and its ramifications for NIH programs, with the first question from the Chair asking Dr. Zerhouni how he will “continue to deliver when you’ve had more than a 10-percent decrease considering inflation, which amounts to about $3 billion.” Dr. Zerhouni responded that it is difficult to support research without a sustained investment over time, and the consequence is that if you “lose purchasing power, the most important impact on the research is loss of scientists.” Senator Specter also asked about the adequacy of funding for the development of a vaccine in the event of pandemic influenza and whether the current funding would permit the cancer genomics initiative to go forward. Senator Harkin asked pointed questions about the lack of funding for the NCS, its priority among other programs, and whether it is really important. Senator Shelby also pressed on the status of research on lupus and treatments for lupus, noting that his wife suffers from lupus.

ATTACHMENT 2
HISTORY OF HOUSE AND SENATE ACTION, WHICH WAS NOT ENACTED FOR FY 2007

HOUSE ACTION

On June 13, 2006, the House Committee on Appropriations marked up and reported out H.R. 5647, the House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies appropriations bill for FY 2007, without change to the Subcommittee-reported version, which was marked up on June 7. NIH would receive an appropriation of $28.350 billion, which is equal to NIH’s President’s budget authority request. House floor action was scheduled for June 21; however, the bill was pulled, in large part because the Minority Whip, Representative Steny H. Hoyer (D-MD), successfully offered an amendment to the bill that would raise the minimum wage by $2.10, to $7.25, over 2 years, and it was not brought to the House floor before the close of the 109th Congress.

The House FY 2007 appropriations bill included language from last year’s bill identifying a maximum of $332 million that may be transferred from NIH ICs to the Common Fund; earmarks of $159.5 million for the advanced development of biodefense countermeasures and $96.030 million for activities related to countering potential nuclear, radiological, and chemical threats; an earmark of $69 million for NICHD for the continuation of the NCS; and language that would require all investigators funded by NIH to “submit an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication to the NIH National Library of Medicine’s PubMed Central as soon as practicable but no later than 12 months after the official date of publication.”

SENATE ACTION

On July 20, 2006, the Senate Committee on Appropriations marked up and reported out S. 3708, the Senate Appropriations Subcommittee on Labor, HHS, Education and Related Agencies appropriations bill for FY 2007, without change to the Subcommittee-reported version, which was marked up on July 18. The bill included $28.5 billion for NIH, an increase of approximately $200 million over the President’s request and the House-reported level, excluding the Global HIV/AIDS Fund transfer. The bill did not reach the Senate floor before the November 2006 elections, nor before adjournment.

The Senate FY 2007 appropriations bill included a maximum of $332 million that may be transferred from ICs to the Common Fund; earmarks of $159.5 million for the advanced development of biodefense countermeasures and $96.030 million for activities related to countering potential nuclear, radiological, and chemical threats; $100 million that may be made available from NIAID for the International Assistance Programs Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis; new bill language permitting funds appropriated to ICs to be expended for improvements and repairs of facilities, not to exceed $2.5 million per project; and report language stating that “the Committee supports full and timely implementation of the Study [NCS] and has included funds within the Office of the Director to continue the study . . . the leadership of the NCS is urged to bring in additional objective scientific expertise to assess the scientific merit of the study components. The Committee further urged the NIH to coordinate the involvement of the Departments, the lead Federal partners and other interested institutes, agencies and non-Federal partners conducting research on children’s environmental health and development, such that this study is ready for the field by no later than 2007.”

ACTION

On June 13, 2006, the House Committee on Appropriations marked up and reported out H.R. 5647, the House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies appropriations bill for FY 2007. On July 20, the Senate Committee on Appropriations marked up and reported out S. 3708, its FY 2007 appropriations bill. In the absence of enacted appropriations, Congress has passed three CRs to provide funding for NIH and other agencies. Floor action did not occur on either H.R. 5647 or S. 3708, and final action on the FY 2007 Labor, HHS, Education and Related Agencies appropriations did not occur until the 110th Congress convened.

ATTACHMENT 3
COMPARISON OF HOUSE AND SENATE PROVISIONS IN FY 2007 BILLS

¹ Text of Section 216 (Flexible Research Authority):

“SEC. 216. (a) AUTHORITY—Notwithstanding any other provision of law, the Director of the National Institutes of Health may use funds available under section 402(i) of the Public Health Service Act (42 U.S.C. 282(i)) to enter into transactions (other than contracts, cooperative agreements, or grants) to carry out research in support of the NIH Roadmap for Medical Research.

(b) PEER REVIEW—In entering into transactions under subsection (a), the Director of the National Institutes of Health may utilize such peer review procedures (including consultation with appropriate scientific experts) as the Director determines to be appropriate to obtain assessments of scientific and technical merit. Such procedures shall apply to such transactions in lieu of the peer review and advisory council review procedures that would otherwise be required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 494 of the Public Health Service Act (42 U.S.C. 241, 284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and 289c).”